Implant

ABSTRACT

A percutaneous implant serves for implantation into an animal or a human body. The implant is of the kind that has an axial interior section for fixation inside the body, an axial exterior section in communication with the interior section and extending outwards from the body with a free end. The free end of the exterior section serves for mounting of a detachable device. A distal end of the interior section opposite the exterior section is provided with an anchoring section, extending radially from the distal end of the interior section. The anchoring section includes an inner anchoring ring extending from or integral with the interior section, an outer anchoring ring, and at least one connection member configured and dimensioned for resiliently connecting the inner anchoring ring with the outer anchoring ring in a manner to provide axial resilience and anchorage to the anchoring section.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of application no. 11/218,905 filedSep. 1, 2005, now U.S. Pat. No. 7,935,096, which in turn claims thebenefit of U.S. provisional application 60/615,576 filed Oct. 5, 2004.

BACKGROUND

The invention relates to a percutaneous implant for implantation into ananimal or a human body.

A method for implantation of the implant according to the presentinvention into an animal or a human body is also described together withpreferred uses.

The implant is of the kind comprising an axial interior section forfixation inside the body, an axial exterior section in communicationwith the interior section, said axial exterior section extendingoutwards from the body with a free end, which serves for mounting of adetachable device, the distal end of the interior section opposite theexterior section being provided with an subcutaneous anchoring section,extending radially from the distal end of the interior section.

Many diseases such as e.g., Crohn's disease, ulcerative colitis,intestinal cancer and adenomatous polyposis or bladder cancer requireremoval of all or part of the intestines or bladder. When the intestinesor the bladder are removed, the bodily wastes are expelled through a newsurgical opening in the abdominal wall. The surgery to create the newopening, the stoma, is called ostomy. The main steps in the surgery areto create an abdominal opening, to externalize an intestine through theabdominal wall and skin, and suture the intestine to the skin so as tocomplete the stoma.

The prior art types of intestinal ostomies are performed depending onhow much and what parts of the intestines are removed. The surgery iscalled an ileostomy if the colon and rectum are removed, in which casean ileostomy is performed by attaching the ileum to the stoma. If therectum is removed, the colon is attached to the stoma to perform acolostomy. Most persons with ostomies must wear special appliances overthe stoma and use ostomy pouches to collect and eliminate waste.

A continent ileostomy is the most preferred alternative to using anoutside collecting bag. An internal reservoir pouch is created from partof the small intestine. A valve is constructed and a stoma is placedthrough the abdominal wall. A tube must be inserted through the stomaand the valve in order to drain the pouch from time to time. The mostcommon kind of continent ileoanal reservoir has a capacity of 500 to1000 mL and a valve made by intussusception of the terminal ileum.

Only for very few patients, ileoanal reservoir surgery is a possiblealternative to a permanent ileostomy. Ileoanal reservoir surgery iscompleted in two surgeries. In the first surgery, the colon and rectumare removed and a pouch or reservoir is constructed from the last partof the small intestine. This pouch is attached to the anus. In thesecond surgery, the ileostomy is closed. The muscles surrounding theanus and anal canal are left in place, so the stool in the pouch doesnot leak out of the anus.

Different kinds of urostomy surgery are used dependent on the diseasecausing the surgery. Usually the ureters are detached from the bladderand joined to a section of the ileum to create an ileal conduit for theurine. One end of this section of ileum is sealed off and the other endis brought to the surface of the abdomen to the stoma to allow urine tobe collected in a urine pouch attached around the stoma.

Alternatively, an uretero-cutaneostomy is possible in which the uretersare detached from the bladder and brought to the surface of the abdomen.A uretero-cutaneostomy can be made as a “single” uretero-cutaneostomy inwhich only one ureter is brought to the surface, a “bilateral”uretero-cutaneostomy with one ureter in each side of the abdomen, a“double-barrel” uretero-cutaneostomy in which both ureters are broughtto the same side of the abdomen but externalized using two holes, or a“transuretero” uretero-cutaneostomy in which both ureters are brought tothe same side of the abdomen and externalized via one common hole.

The above-mentioned methods are drastic surgical procedures of greatdiscomfort to the patient both before and after surgery is completed.

In summary there are several drawbacks with the above conventionalmethods including ulceration, incisional hernia, or bulging of the bowelthrough the incision, narrowing of the stoma, scar tissue and bowelobstruction, marsupialization, avulsion, skin irritation from stool thatleaks under the drainage bag and necrosis.

In addition, use of a stoma pouch for collection of the bodily wastesmust be used for most ostomies. The stoma pouch is conventionallyadhered to the skin by means of an adhesive contact surface on the pouchso as to allow the pouch to surround the stoma for sealingly collectingstool or urine. If liquid secretion penetrates the adhesive surface,this surface will loosen to a certain extent, resulting in leakage fromthe pouch and the release of an unpleasant smell.

Another problem with ostomies is that the site where the intestinepasses the abdominal wall is weak and susceptible to herniation. Herniasresult in blockage of the stoma and relief surgery is urgently required.

A number of implants have been provided in order to remedy theabove-named disadvantages of the above mentioned prior art systemsavailable today for patients having a stomy.

U.S. Pat. No. 4,183,357 discloses a transcutaneous implant for use withenterostomies. The implant consists of a hollow barrel with a protrudingflange, which is permanently positioned under the skin between thedermis and the fascia. The intestine is externalized by drawing theintestine up through the barrel. The barrel surrounds and supports thestoma, however the rigid wall of the implant critically restricts theperistaltic movements.

Similar implant devices for surrounding an enterostomy are disclosed inU.S. Pat. No. 4,217,664 and GB patent No. 2 019 219.

International patent application WO 98/58691 discloses an implant to beused in an intraluminal procedure. A hole is prepared with a pursestring suture in the terminated proximal sigmoideum. The plane contactface of the implant is introduced via a colostomy aperture in theabdominal wall and fitted into the prepared aperture in the sigmoideum.The purse string suture is secured and the sigmoideum wall is broughtinto contact and attached to the parienteral peritoneum surrounding theexterior surface of the implant, the flange part of which is left insidethe sigmoideum. The extent of the anchoring zone between the sigmoideum,the peritoneum and the flange is minimal so that fluctuating tensileforces and compressions resulting from peristaltic movements are notrestricted. Use of this device involves a high risk of total or partialrupture between tissue and implant, e.g. in case of high back pressureresulting from constipation. Urine or stool may leak and causeinflammation and peritonitis. Thus, improvements in these type devicesare desired.

SUMMARY OF THE INVENTION

In a first aspect according to the present invention, a percutaneousimplant of the kind mentioned in the opening paragraph is provided,which can be used in ostomy without externalization of a vessel, such asan intestine or a ureter, through the abdominal wall.

In a second aspect according to the invention, an implant is provided,which provides a stable, effective and well vascularized skin-implantjunction.

In a third aspect according to the invention, an implant is provided,which is able to conform to and keep pace with any peristaltic movementsor mechanical stress.

In a fourth aspect according to the invention, an implant is providedwhich is not sensed by the patient after implantation, and which can bedetachably attached to and disconnected from devices, such as e.g. capsor pouches, thereby giving the surgically treated patient anunprecedented comfort.

In a fifth aspect according to the invention an implant is providedwhich causes an unprecedented minimum of allergic and inflammatoryreaction.

The novel and unique features, whereby this is achieved according to thepresent invention, is the fact that the anchoring section comprises aninner anchoring ring extending from or integral with the interiorsection, an outer anchoring ring, and at least one connection member forconnecting the inner anchoring ring with the outer anchoring ring.

The problem of establishing a leak proof zone between the implant andthe enterostomy is solved according to known prior art implants byeither entirely enclosing the externalized vessel or by placing at leasta part of the implant inside the lumen of the vessel. In contrast, theimplant according to the present invention is situated on top of thevessel wall. For example, if the vessel to be brought in fluidcommunication with the exterior is the small intestine, the lower faceof the anchoring section can be placed directly on the selected spot onthe fascia above the intestinal serosa and secured in situ, e.g. bymeans of sutures, tissue glue or staples. The exterior section of theimplant is externalized through an access hole in the abdominal wall andthe upper face of the anchoring ring is brought into contact with theepithelium of the peritoneum and secured in a similar manner as thelower face of the anchoring section. Finally the contact zone is left toheal up. In this simple manner the vessel and peritoneum covering thefascia is fused together in the area adjacent the anchoring section.Gradually, a natural, strong adherence is spontaneously generatedbetween the implant, vessel, and peritoneum.

The anchoring section ends up infiltrated with vascularized connectivetissue, which ensures that a strong, and reliable attachment levelbetween the wall of the vessel, the peritoneum/fascia, Mm. abdominis andthe implant can be obtained. The access opening in the vessel may becreated at any time during the procedure to finally allow the stool toescape. Scar formation can be kept to a minimum and only the intestinalmucosa will, as usual, be in direct contact with stool. Accordingly therisk of inflammation and/or infection is also minimal.

When a first connection point between a first end of the at least oneconnection member and the inner anchoring ring is angularly offset froma second connection point between a second end of the connection memberand the outer anchoring ring, the rings together with the connectionmembers act as an axially resilient, circumferential spring means, whichis able to respond to any movements and/or to absorb shear of theimplant in relation to the adjacent organs, without damaging theestablished, biological connective tissue adherences.

In a preferred embodiment the inner diameter of the outer anchoring ringis greater than the outer diameter of the inner anchoring ring. Theradial distance between the rings contributes to the flexibility andresiliency of the anchoring section, but also the chosen material andthe material thickness are of significant importance to flexibility.

Preferably, the at least one connection member is S-shaped. Said S-shapehas shown to provide the anchoring section with a high level ofrequisite resiliency. A main part of the connective tissue is createdand integrated in the gaps between the components of the anchoringsection and this connective tissue fusion constitutes in co-operationwith the rings an elastic coupling of the implant to the body when thepatient and/or the organs or implant move beyond control of the patient.

In one advantageous embodiment according to the present invention theanchoring section extends at an angle of approximately 90-110° ,preferably 90° from the interior section, so as to substantially followthe curvature of the internal abdominal wall at the area of the accesssite in said abdominal wall.

A seal and connection of the anchoring section between the intestinalserosa and the epithelium of the peritoneum can be easily obtained if atleast one of the inner anchoring ring, the outer anchoring ring and theat least one connection member is provided with through- goingtransverse openings. Such openings may have different sizes and allowfor ingrowths of connective tissue and subsequent vascularization of thecreated connective tissue.

It is further preferred that at least one of the inner anchoring ring,the outer anchoring ring or the at least one connection member has across-section with rounded edges, preferably a substantially circularcross-section, to form a smooth tissue junction between the connectivetissue which traverses and surrounds the respective components of theimplant.

Rounded edges have the important advantage that no cutting action occurswhen the implant moves slightly in response to organ movements andphysical action of the person wearing the implant. The risk of avulsionis further prevented by means of this design.

Yet a further and very important advantage of rounded edges over edgededges is the fact that the new tissue, which is gradually created aroundparts of the anchoring section and through the through-openings, isenabled to create a solid, fluid-proof seal between implant parts andsurrounding tissue, especially the accessed intestine.

For this reason it is most preferred that all of at least one of theinner anchoring ring, the outer anchoring ring or the at least oneconnection member has a cross-section with rounded edges. In case thesurgeon prefers to use tissue glue for attachment of the anchoringsection to the vessel, said tissue glue may be advantageously applied inadvance to at least one surface on the anchoring section. For examplethe said surface may be coated with a biologically acceptable tissueglue, optionally covered by a peelable foil, so that the implant is easyto maneuver inside the body without sticking to unintended sites duringattempt to place the implant correct in situ.

Commercially available tissue glues are known to the person skilled inthe art of surgery and may e.g. be selected from the group consisting ofcyanoacrylates, fibrin sealants or combinations of these. Fibrin sealantis a non-toxic, biological product that can stimulate wound healing andreduce hospital stay.

A sheet of mesh, such as e.g., monofilament polypropylene mesh, havingapproximately the same size as the area of the lower anchoring facedefined by outer periphery of the anchoring section, can advantageouslybe provided on and cover the lower face of the anchoring section. Themesh can be glued to any part of the lower face of the anchoring sectionnot provided with through-going transverse openings and serves as asealing material between fascia and anchoring section.

In a preferred embodiment according to the present invention the mesh isfirmly adhered by means of biological acceptable glue to both theelongated connection members and the part of the axial interior sectiondefined by the distal wall thickness.

A central portion of the mesh has a radius, which correspondsapproximately to the radius of the inner anchoring ring of the implant.This central portion is saturated with the biological acceptable glue,which in solidified condition provides a fluid barrier across the totalthickness of the mesh at the entire radial distance of the centralportion. This barrier is effective as a seal in the area of contactbetween implant, mesh and fascia. None of the through-going transverseopenings in the implant are covered or filled with glue. Accordingly,tissue in-growth and vascularization conditions are excellent.

The central portion can preferably have a central guiding hole forguidance of the trocar of a surgical cutting and stapling device, thusensuring correct position of the surgical cutting and stapling device. Asuitable device is designed for in a first step carefully penetratingthe respective layers to be anastomosed. In the second step a circularsection is cut out in one single operation of the pressed togetherlayers of overlaying layers of glue saturated mesh, fascia, peritoneumand intestinal wall to provide an outlet opening which allow the contentof the vessel to escape freely into the bore of the implant for disposalwhen required. Simultaneously the surgical cutting and stapling devicestaples the created circumferential walls of the holes of the gluesaturated mesh, fascia, peritoneum and intestinal wall sealinglytogether with the inner anchoring ring and the mesh. The healing processincluding tissue in-growth and vascularization, is initiated by thenatural mechanism. Surgical cutting and stapling device devices arecommercially available and will not be described in greater detail here.Various suitable surgical cutting and stapling devices for use in thesurgical procedure according to the present invention is obtainable frome.g. Ethicon Endo-Surgery, Inc., 4545 Creek Road, Cincinnati, OH45242,USA.

A suitable device is selected according to the required diameter of thestoma. As an example of suitable devices can be mentioned various sizesof Proximate ILS, straight Intraluminal Stapler, from EthiconEndo-Surgery Inc.

The solidified and integrated glue structure of the central portion ofthe mesh has the further advantage of stiffening the central portionthereby promoting proper and fast identification of the guiding hole bythe trocar of the surgical cutting and stapling device for furtherpenetration through fascia, peritoneum and intestinal wall.

The presence of the sealing material effectively prevents fluid, whichflows in the accessed vessel, e.g. an intestine, from leaking in betweenthe joined layers of various tissues and implant. The mesh furtherpromotes strong tissue in-growth and body acceptability of the implantand reduces time of healing.

The central portion can in an alternative embodiment be made of anothertype of mesh having a closed pore structure and is thicker than the restof the central portion.

Also a tissue mesh is foreseen within the scope of the presentinvention. A preferred tissue mesh is an autograft.

The implant according to the present invention is made of at least onebiologically acceptable material. Preferably the implant is made oftitanium, due to the strength, workability and biological acceptability,but other materials or combinations of materials recognized within theart are also within the scope of the present invention. Otherbiologically acceptable material materials or combinations of materialsare foreseen within the scope of the present invention. E.g. the implantcan be made of a polymeric material solely or of two materials ofdifferent hardness, e.g., polymeric material-metal. The polymericmaterial can e.g. be a thermosetting and the metal e.g. NITINOL® or theabove mentioned titanium.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention is described in more detail below, exclusively describingexamples of embodiments with reference to the drawing, in which

FIG. 1 shows, in perspective, an implant according to the presentinvention and a closure plug for insertion into the bore of the implant,

FIG. 2 shows a top view of the implant according to the presentinvention,

FIG. 3 shows a section of the implant of FIG. 1 taken along the line Theimplant is seen schematically in a first implantation step immediatelyafter implantation according to a first embodiment of a surgicalprocedure,

FIG. 4 shows the same but the implant is implanted according to a secondembodiment of a surgical procedure,

FIG. 5 shows on an enlarged scale a perspective view of a detail of amodification of the anchoring section seen in FIG. 1,

FIG. 6 shows in an exploded view the lower face of the implant of FIG. 1provided with a sealing mesh; the locations of the glue applications areindicated separately,

FIG. 7 shows the embodiment shown in FIG. 6 in a position ready forimplantation,

FIG. 8 shows a section of the implant of FIG. 7 taken along the lineVII-VII. The implant is seen schematically after implantation on top ofan intestinal vessel in a first step of a surgical implantationprocedure using a conventional cutting and stapling device, and

FIG. 9 shows the same in a third step of the surgical implantationprocedure.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The implant shown in FIGS. 1 and 2 is in its entirety designated withreference number 1. The implant 1 is only by way of an example shown inthe drawing implanted in relation to the ileum, however the use with anyother vessel is intended within the scope of the present invention.

FIG. 1 shows an implant 1 with an axial exterior section 2, an axialinterior section 3, from which an anchoring section 4 extends radiallyin an angle a of approximately 90° . The anchoring section 4 consists ofan inner anchoring ring 5, an outer anchoring ring 6 concentric with theinner anchoring ring 5 and three elongated connection members 7 a,7 b,7c for connecting the inner anchoring ring 5 with the outer anchoringring 6. As seen best in FIG. 2 the connection member 7 b is connected ata substantially right angle to the inner anchoring ring 5 at a firstconnection point 8 b, and at a substantially right angle to the outerconnection ring 6 at a second connection point 9 b. In a similar mannerthe connection members 7 a,7 c are connected to the rings 5,6.

The connection points 8 a,8 b,8 c between the connection members 7 a,7b,7 c and the inner anchoring ring 5 are circumferentially, angularlyoffset from the connection points 9 a,9 b,9 c between the connectionmembers 7 a,7 b,7 c and the outer anchoring ring 6 at an angle β. Thesubstantially right connection angle and the angular offset β give theconnection members substantially an S-shape. However, within the scopeof the present invention the connection members can be connected to therings at different angles a, such as e.g. an acute angle of 45° .

The outer anchoring ring 6 has a greater diameter than the inneranchoring ring 5. The circumferentially, angularly offset joining of therings 5,6 obtained by means of the connection members 7 delimitelongated circumferential gaps 10 a,10 b,10 c between the rings 5,6. Thecombination of gaps 10 and connection members 7 provide the desiredresiliency of the anchoring section 4 in order for this section toabsorb external stresses acting on the skin and the implant keeping theinternal region free of stress.

The inner 5 and outer anchoring ring 6 have a plurality of through-goingtransverse openings 11 a,11 b,11 c with identical or differentdiameters. The openings 11 serve for in-growth of connective tissue andvascularization.

In addition, in a preferred embodiment some of the openings 11 are usedas suturing holes when the ileum, fascia and peritoneum are to joined,e.g. by means of sutures, to allow healing and formation of connectivetissue.

The axial exterior section 2 extends outwards from the body with a freeend 12, which is adapted for mounting a detachable device, such as aclosure plug 13, a cap or an ostomy pouch (not shown).

When the closure plug 13 is inserted in the tubular bore 14 of theimplant 1, stool is prevented from being expelled. The lumen of theexternalized intestine serves as a temporary reservoir and must beemptied from time to time. The peristaltic movements promote emptying.Alternatively conventional irrigation means can be used to assistemptying of stool accumulated in the intestinal reservoir.

The axial exterior section 2 is furthermore provided with a plurality ofcircumferential ribs 15, intended for promoting firm mechanical securingof the exterior section to the surrounding tissue. Furthermore the ribsimpede downgrowth of epithelium.

The exterior section may furthermore be equipped with various couplingmeans for the properly sealed attachment of caps and pouches. Such meansinclude but are not limited to recesses or indentations, O-rings,snap-fitting means, bayonet coupling means, locking rings etc.

A surgical procedure is now described by way of example with referenceto FIG. 3. The first step in the surgical procedure is to make a firstvertical incision through the abdominal wall down to the fascia 17. Thisincision is made approximately 5-10 cm from the site where the implant 1is to be located. Next the fascia 17 is separated from the Mm. abdominis18 by dilatation to create a gap for the later introduction of theimplant 1 and permanent location of the anchoring section 4 betweenfascia 17 and Mm. abdominis 18.

An access hole 20 for the implant 1 is surgically created through theskin 19 and further through the detached tissue layers 18 of theabdominal wall by means of punching, cutting and blunt dissection,taking precautions not to penetrate the intestine 21 at this earlysurgical step.

The required surgical procedure, e.g. removal of a malfunctioning ordiseased section of the intestine, optional refashioning of theintestine to create a reservoir such as e.g. a Koch's reservoir, andclosure of any intestinal residues left in situ, is then performed.

Now the implant 1 is introduced via the first incision into the createdgap between the fascia 17 and the Mm. abdominis 18. The axial exteriorsection 2 is passed through the access hole 20 such that the free end 12protrudes a small distance from the body. The anchoring section 4 isplaced directly on the fascia 17 above the spot on the intestine 21,which is to be brought into communication with the exterior via the bore14 of the implant 1. To avoid displacement of the implant 1 in relationto the intestine 20 and abdominal tissue, including the fascia 17 andthe peritoneum 22, different kinds of attachment means and systems canbe used.

Optionally, the outer wall of the axial exterior section 2 including theribs 15 may be further secured to the wall of the access hole 20 bymeans of tissue glue or sutures (not shown) if necessary.

An import aspect is to create a superior tight connection betweentissues and implant. By creating a superficial lesion on the exterioroutside of the intestinal wall and optionally a correspondingsuperficial lesion on the epithelium of the peritoneum, so as to enhanceinclination to produce natural adherences, the natural tendency tocreate adherences is advantageously utilized. Since the fascia in anearly surgical step is separated from Mm. abdominis, both fascia and Mm.abdominis are lesional and strongly inclined to grow together again.Consequently, a natural strong connective tissue adherence, which keepsthe implant in situ, and which connects the intestine with the implantand the adjacent tissue can be established by natural healing procedurein a very simple manner.

In one embodiment, as seen in FIG. 3, the implant 1 is initiallycombined with the relevant section of the intestine 21 and thefascia/peritoneum 17;22 by means of a number of sutures 23 through atleast some of the plurality of holes 11 a,11 c of the inner anchoringring 5 and the outer anchoring ring 5, respectively. Optionally, anytissue overlaying the upper face of the anchoring section 4 can also besecured to the implant by means of said sutures 23 (or other sutures) ifappropriate to avoid preliminary dislocation of the implant 1.Eventually the sutures 23 will dissolve or be digested by the body.

In a second embodiment, as seen in FIG. 4, the sutures 23 aresubstituted by tissue glue layers 24 a, which attach the lesional serosaof the intestine to the epithelium of the peritoneum 22, and tissue gluelayer 24 b, which attaches the lower face of the anchoring section 4 tothe fascia 17. Optionally, the upper face of the anchoring section 4 canalso be glued to adjacent tissue. Such tissue glue is very suitable forperforming a highly strong joining of biologically acceptablecomponents, and will be absorbed eventually leaving a tight pressureresistant vascularized skin-implant junction. The glue may be appliedeither on the tissue or on a surface of the implant. In a very simpleembodiment the glue may also be precoated on the implant.

The outlet opening in the ileum 21 is made whenever appropriate via theaccess opening 14 of the implant 1 using e.g. a scalpel or another otherappropriate surgical cutting tool.

A detail of a preferred embodiment of the implant according to thepresent invention is shown in enlarged scale in FIG. 5. The roundededges of the components of the anchoring section 4 ensure that thecutting action from the edges of the components of the implant iseliminated. In addition a strong seal of connective tissue can formaround and conform to said components. Especially preferred is acircular cross-section of the connection members 7.

An especially preferred modification of the embodiment of the implantaccording to the present invention shown in FIG. 1 is shown in FIGS. 6and 7.

In the exploded view of FIG. 6 a circular mesh 25 with a guiding hole 26are provided on the entire anchoring section 4, as seen best in FIG. 7.The mesh 25 has an open pore structure.

By means of a biological acceptable glue 27 d,27 a,27 b,27 c, thecircular mesh 25 is adhered to only the inner anchoring ring 5 and theelongated connection members 7 a,7 b,7 c, respectively.

The glue cake 27 d fills the pore structure of the central portion 28 ofthe mesh 25 as seen best in FIG. 7.

The initial step of implantation of this embodiment corresponds to theembodiment shown in FIG. 3. The subsequent procedure is described aboveand illustrated in the sectional views of FIGS. 8 and 9 demonstratingsecuring the implant to the subjacent layers by means of staples. Thesame numerals are reused for like components.

The staples 29 have the advantage that conventional available surgicalinstruments can be used as described above. They are known to thesurgeon, easy to use and the entire securing of the implant is donewithin minutes. Furthermore, the staples 29 squeezes and holds the mesh25, the fascia 17, the peritoneum 22 and the wall of the intestine 21firmly and sealingly tight together during the healing, preventing fluidfrom penetrating in between these components and layers. The risk ofirritation and inflammation is thereby considerably reduced.

As can be seen from FIG. 9 the circumferential wall of the cut-outextend a small distance into the bore of the implant to establish asmall protrusion for the staples. In case the circumferential protrusionis of inconvenience to the patient the protrusion and the staples caneasily be removed as soon as a sealingly tight and firm attachment isensured.

Securing of the anchoring section 4 on top of the fascia 17 can be madeusing any of the means sutures, glue, staples and any appropriatecombinations of these means.

The first incision is closed and precautions may be taken not to putextensive load on the surgical structure for the first few days aftersurgery. In order not to stress the healing procedure and put pressureon the connection between any tissue and the implant, stool must beallowed to escape freely during an initial period during which thepatient may be equipped with a conventional ostomy pouch. In addition adiet can be prescribed, e.g., an astronautic diet for reducing stoolformation.

Eventually, when the adherence between organs, tissue and implant hasbeen proved strong enough, the plug 13 can be placed in the bore 14 ofthe implant 1. Whenever appropriate, the plug 13 is removed in order todrain the reservoir of the externalized intestine 21. Disposable plugs13 may be preferred by some patients. An O-ring 13′ can be providedaround the plug 13 to further ensure air and liquid sealing capability.

In most cases there is no need to create an intestinal reservoir sincethe intestinal wall will itself adapt to the new conditions and developa pressure resistant thickened wall.

The surface characteristics of the implant are important to facilitateand improve healing with connective tissue. In order to give a surfaceroughness that promotes interaction and healing with tissue the proximalexterior section is in a preferred embodiment brightly polished and thedistal exterior section, the interior section and the anchoring sectionare blasted, preferably with aluminum oxide, or coated with surfacecoating.

It is further preferred to provide each implant with a unique identifierto be able to trace the implant and problems that might relate toproduction, e.g. choice of material and design, and to collect andrecord relevant data in an anonymous manner. The implant can be madevery small and since various collecting and closure devices can bedetachably attached to the free end of the exterior section of theimplant, bodily waste can be expelled when and where it is appropriate.The patient is offered a hitherto unknown degree of freedom to behaveand live an almost normal life.

1. A percutaneous ostomy implant for implantation into an animal or ahuman body, comprising: an axial interior section for fixation insidethe body, an axial exterior section in communication with the interiorsection and extending outwards from the body with a free end, said freeend of the exterior section serving for mounting of a detachable device,and a distal end of the interior section opposite the exterior sectionis provided with an anchoring section, extending radially from thedistal end of the interior section, wherein the anchoring sectioncomprises an inner anchoring ring extending from or integral with theinterior section, an outer anchoring ring, and at least one connectionmember configured and dimensioned for resiliently connecting the inneranchoring ring with the outer anchoring ring in a manner to provideaxial resilience and anchorage to the anchoring section.
 2. The implantaccording to claim 1 wherein the outer anchoring ring has an innerdiameter that is greater than the outer diameter of the inner anchoringring and each connection member has a shape that defines at least onegap or opening between the inner anchoring ring and the outer anchoringring.
 3. The implant according to claim 2 wherein at least twoconnection members are provided, each extending from the inner ring tothe outer ring in a plane therebetween to provide said axial resilienceand anchorage to the anchoring section.
 4. The implant according toclaim 3 wherein each connection member defines a gap having first andsecond gap parts that are of different lengths and which delimit andoverall elongated circumferential gap between the inner anchoring ringand the outer anchoring ring.
 5. The implant according to claim 1,wherein the anchoring section extends from the distal end of theinterior section at an angle a of approximately 90-110° and theanchoring section extends from the distal end of the interior section atan angle a of approximately 90° .
 6. The implant according to claim 1,wherein at least one of the inner anchoring ring, the outer anchoringring or the at least one connection member has a substantially circularcross-section.
 7. The implant according to claim 1, wherein a lower faceof the anchoring section is covered with a polypropylene or tissue mesh.8. The implant according to claim 7, wherein the mesh is adhered to theinner anchoring ring and the elongated connection members by means of abiological acceptable glue.
 9. The implant according to claim 8, whereinthe mesh has a central portion which is either of a different porestructure or a different thickness than the rest of the mesh or issaturated with glue.
 10. The implant according to claim 8, wherein thecentral portion has a guiding hole.
 11. The implant according to claim1, wherein at least one surface on the anchoring section is coated witha biologically acceptable tissue glue and the anchoring section and glueare covered by a peelable foil.